This study aims to find out whether ZEISS MyoActive lenses can help prevent short-sightedness from developing in children. We aim to recruit at least 50 children in total for this study.
Myopia (short-sightedness) is becoming increasingly common in children worldwide. Early onset of myopia often leads to faster progression and a higher chance of developing high myopia, which increases the risk of serious eye conditions that can affect vision in adulthood, such as retinal detachment, glaucoma, and cataracts. Current treatments can slow the worsening of short-sightedness once children become myopic, but there is limited evidence on whether early intervention can delay myopia from developing in the first place.
This study will compare two types of commonly used spectacle lenses:
ZEISS MyoActive lenses, which are designed to provide a type of optical signal that may reduce the worsening of short-sightedness; and Standard single-vision lenses, which are the usual lenses prescribed for clear vision.
Children who join the study will be randomly assigned to wear one of these two lens types for 12 months. They will attend regular check-ups during this time so we can monitor their eye health and vision.
By randomly assigning children to one of these two lens types and following them over 12 months, we aim to determine whether ZEISS MyoActive lenses:
reduce the likelihood of developing short-sightedness, slow changes in how short-sighted a child's eyes are becoming and eye growth, and are safe, comfortable, and well-tolerated for everyday use. The findings from this study may help improve early myopia prevention strategies and potentially reduce future risks of high myopia and its associated eye conditions.
be accompanied by a parent or guardian who is able to read and comprehend English and sign a record of informed consent/assent;
be able to understand and participate in the Assent process;
at baseline, be within the age range of 6 to 12 years old inclusive;
No prior spectacle correction
Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error;
Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus.
Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the study. NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the study product is used.
History of eye trauma
Parallel
Zeiss MyoActive lenses
DeviceThe novel ZEISS MyoActive lens was designed to introduce simultaneous myopic defocus at the retina. Early studies, including interim results from the ongoing trial NCT06563700, have shown promise in reducing myopia progression in already-myope children. However, its utility in pre-myopic children remains underexplored, and no current optical strategy has been validated for delaying the transition from pre-myopia to clinical myopia.
Single Vision Lenses
DevicePatients will be fitted with a pair of plano single vision glasses.
Change in cycloplegic objective spherical equivalent refractive error (dioptres) with ZEISS MyoActive spectacle lenses compared to plano single vision (SV) spectacles at 12 months.
Change from baseline in axial length (mm) with ZEISS MyoActive spectacle lenses compared to single vision (SV) control lenses at 12 months.
Motivation to use myopia control interventions in carers of children with pre-myopia as assessed by motivation questionnaire at 12 months.
Compliance with ZEISS MyoActive spectacle lens wear in children with pre-myopia, as measured by patient reported questionnaire at 12 months
Change from baseline in choroidal thickness (µm) in children wearing ZEISS MyoActive spectacle lenses compared to single vision lenses at 12 months.
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Singapore National Eye Centre
Lead sponsor
Duke-NUS Graduate Medical School
Collaborator
ZEISS Vision Care
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
